Validation of a Hypoparathyroidism Self-questionnaire

NCT05642741 | Completed

• 1 other identifier: RC22_0495
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate, for patients with post-thyroidectomy hypoparathyroidism (HoPT), the severity of their HoPT and to validate clinical scores from a self-administered questionnaire related to this disease (questionnaire which evaluates the severity of clinical symptoms related to HoPT and their impact on quality of life) in order to assess the severity of HoPT and to optimize support.

Conditions

Thyroidectomy; Hypoparathyroidism Postprocedural

Keywords

Total thyroidectomy; Hypoparathyroidism Postprocedural; Quality of life; Self-questionnaire

Outcome Measures

Primary Outcomes (1)

• Validate two clinical scores (a symptom importance score and a symptom impact score in daily life) from a questionnaire adapted to hypoparathyroidism, in order to better assess the severity of HoPT and optimize management.

  To psychometrically validate the two scores created with the hypoparathyroidism severity questionnaire by showing, on the one hand, a good fit to a confirmatory two-dimensional factorial model (RSMEA\<0.08 and CFI\>0.9) and, on the other hand, by showing the good internal consistency of each of the scores (Cronbach's alpha \>0.7).

  3 weeks

Secondary Outcomes (3)

• Discriminant validation : correlate hypoparathyroidism severity scores with biological results (PTH, calcemia, calciuria)

  3 weeks

• Concurrent validation of scores: correlate hypoparathyroidism severity scores with patients' quality of life scores (SF36)

  3 weeks

• Reproducibility of scores: show stability of scores at 3 week intervals (+/- 7 days)

  3 weeks

Study Arms (1)

Hypoparathyroidism after total thyroidectomy

Adult patients definitive post-thyroidectomy HoPT defined by a parathyroid hormone (PTH) concentration ≤ 25 pg/mL more than 6 months after the operation and who require treatment with vitamin D and/or calcium supplementation. Each patient will complete a questionnaire twice (3 weeks apart +/- 7 days). The questionnaire, which evaluates the severity of clinical symptoms related to HoPT and their impact on quality of life, is adapted to this pathology.

Other: Response to medical and research questionnaires

Interventions

Response to medical and research questionnaires OTHER

Patients will receive by mail or email the study information note, the medical questionnaire, the SF36 and the research questionnaire to be completed (then again 3 weeks later). The patients will return the questionnaires by mail or by post.

Hypoparathyroidism after total thyroidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients who have undergone total thyroidectomy and who have definitive hypoparathyroidism

You may qualify if:

• Major patient
• Patients undergoing total thyroidectomy
• Patients with permanent hypoparathyroidism defined by a parathyroid hormone concentration ≤ 25 pg/mL more than 6 months after surgery and who require vitamin and calcium therapy.
• Not being opposed to participating in the study (questionnaires will be sent with the study information note. If the patient returns the questionnaires: we will consider that he/she is not opposed to participate in this study)
• Participants must be affiliated to a social security system

You may not qualify if:

• Pregnant women when filling out questionnaires (the child's parathyroids can correct the mother's hypoparathyroidism)
• Minors or protected patients (under guardianship)
• Patients under court protection
• Patients on long-term vitamin-calcium therapy after total thyroidectomy whose PTH concentration has not been controlled or whose concentration is higher than 25 pg/mL.
• Hypoparathyroid patients of other origin than post-thyroidectomy

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fondation SantéDige: collaborator
• Association Francophone de Chirurgie Endocrinienne (AFCE): collaborator

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Study Officials

• Eric MIRALLIE

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: May 2, 2023
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)